Follow-up with OM-8980 after a double-blind study of OM-8980 and auranofin in rheumatoid arthritis
Follow-up with OM-8980 after a double-blind study of OM-8980 and auranofin in rheumatoid arthritis
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OM-8980 和金诺芬治疗类风湿性关节炎的双盲研究后，OM-8980 的随访
DOI：
10.1007/bf02114396
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发表时间：
1990
影响因子：
3.4
通讯作者：
T. Vischer
中科院分区：
文献类型：
--
作者：
T. Vischer
摘要对 145 名类风湿性关节炎患者进行了为期 6 个月的 OM-8980 和金诺芬双盲研究，随后进行了为期 6 个月的开放观察期，在此期间可以对 100 名接受 OM-8980 治疗的患者进行评估。在第二阶段结束时，相对于双盲阶段 OM-8980 和金诺芬记录的显着改善，里奇指数、肿胀关节数量、疼痛量表、晨僵、握力和 ESR 均得到进一步改善。对Ritchie指数、疼痛量表和ESR的统计分析显示，这3个参数在6个月的随访阶段和整个12个月期间均发生了显着变化。至于耐受性，2名患者在随访期间报告出现胃肠道疾病。研究人员对疗效的最终评估表明，76% 的患者在随访阶段有所改善，95% 在整个 12 个月期间有所改善。
SummaryA 6-month double-blind study of OM-8980 and auranofin in 145 patients with rheumatoid arthritis was followed by an open observation period of 6 months for which 100 OM-8980-treated patients could be assessed. At the end of this second phase, the Ritchie index, number of swollen joints, pain scale, morning stiffness, grip strength and ESR had all improved further with respect to the significant improvements already recorded under OM-8980 and auranofin in the double-blind phase. The statistical analysis of the Ritchie index, pain scale and ESR showed significant changes in these 3 parameters during both the 6-month follow-up phase and the entire 12-month period. As regards the tolerance, 2 patients reported gastrointestinal disorders during the follow-up. The investigators' final assessment of efficacy indicated an improvement in 76% of the patients during the follow-up phase and in 95% during the entire 12-month period.